15165
Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
TABLE 2.鈥擡STIMATED BURDEN FOR VOLUNTARY REPORTING
Average time
Number of Annual hour
Type of respondents Frequency of response per response
respondents burden
(hours)
Drugs and Biologics ........................................ 5,400 1 New ............................................................. 7 37,800
8 Updates ....................................................... 2 86,400
Devices ........................................................... 545 1 New ............................................................. 7 3,815
8 Updates ....................................................... 2 8,720
Other ............................................................... 5,280 1 New ............................................................. 7 36,960
8 Updates ....................................................... 2 84,480
Total Voluntary ......................................... 11,225 ......................................................................... ........................ 258,175
these trials into compliance with the
ClinicalTrials.gov. These respondents
The combined, recurring burden for
new information collection
have already provided information
mandatory and voluntary reporting
requirements will be significantly less
collected under the previous OMB
would be the sum of the totals in Tables
than for a new trial registration and is
clearance and will provide only the
1 and 2, or 348,910 hours. This figure
estimated as 3 hours. Information for
additional elements subject to this
would be expected to decline over time
these trials will need to be updated to
clearance. The number of trials subject
as registrants become more familiar with
reflect the continued progress of the
to this requirement is estimated by
the registration processes and refine
trial. The number of updates is
searching the existing ClinicalTrials
their data submission systems.
estimated to be 4, which is half of the
registry for ongoing, interventional
During the first year of
updates estimated for new registrations.
Phase 2鈥?4 studies of drugs, biologics,
implementation, there will be an
Each update is estimated to require 2
and devices. Doing so produces an
additional mandatory reporting burden
hours, consistent with the updates for
estimate of 7,650 trials: 7,000 previously
associated with the collection of
newly registered trials. The total burden
registered trials of drugs and biologics
information for applicable trials of
associated with the updating of
and 650 previously registered trials of
drugs, biologics, and devices that were
information for ongoing trials is 84,150
devices. It is anticipated that
ongoing as of December 26, 2007, but
hours, as shown in Table 3.
information collection required to bring
had been previously registered with
TABLE 3.鈥擡STIMATED BURDEN FOR MANDATORY UPDATING OF INFORMATION FOR ONGOING TRIALS
Average time
Number of Annual hour
Type of respondents Frequency of response per response
respondents burden
(hours)
Drugs and Biologics ........................................ 7,000 1 Compliance Update .................................... 3 21,000
4 Subsequent Updates .................................. 2 56,000
Devices ........................................................... 650 1 Compliance Update .................................... 3 1,950
4 Subsequent Updates .................................. 2 5,200
Total ................................................................ 7,650 ......................................................................... ........................ 84,150
There are no Capital Costs, Operating Costs or Maintenance Costs to report.
best assured of having their full effect if
Direct Comments to OMB: Written
Request for Comments: Written
received within 15 days of the date of
comments and/or suggestions regarding
comments and/or suggestions from the
this publication.
the item(s) contained in this notice,
public and affected agencies should
especially regarding the estimated
address one or more of the following Dated: March 14, 2008.
public burden and associated response
points: (1) Evaluate whether the Betsy L. Humphreys,
time, should be directed to the Office of
proposed collection of information is Deputy Director, National Library of
Management and Budget, Office of
necessary for the proper performance of Medicine, National Institutes of Health.
Regulatory Affairs. All comments
the function of the agency, including [FR Doc. E8鈥?5824 Filed 3鈥?20鈥?08; 8:45 am]
should be sent via e-mail to
whether the information will have BILLING CODE 4140鈥?01鈥揚
OIRA_submission@omb.eop.gov or by
practical utility; (2) Evaluate the
fax to 202鈥?395鈥?6974, Attention: Desk
accuracy of the agency鈥檚 estimate of the
Officer for NIH. To request more
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15166 Federal Register / Vol. 73, No. 56 / Friday, March 21, 2008 / Notices
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